This is a phase II study evaluating the feasibility of concurrent carboplatin given with focal radiation therapy in children age 12 months to \< 21 years with newly diagnosed localized ependymoma who have no or minimal residual disease post-operatively (\< 0.5 cm). The hypothesis is that utilizing carboplatin as a radiosensitizer is feasible and tolerable and may improve event-free survival (EFS) and minimize local recurrences as compared to historic controls. Following a neurosurgical resection and staging, patients who meet the eligibility criteria will receive standard fractionated radiation therapy at doses of 54 to 59.4 Gy to the primary site depending upon age. All patients will receive 35 mg/m²/day of carboplatin prior to each fraction of radiotherapy. Although significant neutropenia is not anticipated, G-CSF will be administered per study guidelines during radiation if neutropenia occurs. All patients will be followed for toxicity, response (resolution of residual disease) and event-free survival (EFS). Patients' tumor sample, blood and cerebro-spinal fluid (CSF) will also be prospectively evaluated to quantify the level of Survivin, a known inhibitor of apoptosis, via immunohistochemistry, Western Blot Analysis (in tumor tissue) and ELISA (in blood and CSF). The feasibility of obtaining these levels prospectively and in real time will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Patients will receive daily carboplatin as a radiation sensitizer prior to radiation each day.
Children's Memorial Hospital
Chicago, Illinois, United States
Measure the EFS of newly diagnosed non-metastatic ependymoma patients treated with a combination of daily carboplatin as a radiosensitizer and conformal radiotherapy.
Time frame: 3 years
Explore the tolerability, feasibility and toxicities associated with daily carboplatin as a radiosensitizer in patients with newly diagnosed non-metastatic ependymoma receiving focal fractionated radiotherapy.
Tolerability and toxicity will be measured by documenting the toxicities associated with this treatment using the current CTCAE version 4.0. The feasibility of this therapy will be measured by observing the ability to finish therapy without delays and the ability to receive daily carboplatin and radiation in the time alloted by the study (within 4 hours) on a daily basis. Delays in therapy will be documented in an effort to define both tolerability and feasibility.
Time frame: 1 year
Explore the overall survival (OS) in patients with newly diagnosed non-metastatic ependymoma treated with this regimen.
Time frame: 3 years
Evaluate the feasibility of quantifying Survivin expression in primary ependymoma tumor, blood and CSF samples in a prospective fashion.
Time frame: 6 months
Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) and tumor histology.
Time frame: 3 years
Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) and patient responses.
Time frame: 3 years
Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) and survival outcomes.
Time frame: 3 years
Explore trends or relationships between Survivin expression (in tumor, blood and CSF samples) tumor recurrences.
Time frame: 3 years
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